Skip to main content
OpenTrials
Completed

NCT Number: NCT02236858

Clinical Trial of Air Cleaners to Improve Indoor Air Quality and COPD Health

Objectives (include all primary and secondary objectives)

Specific Aim #1: To determine whether an air cleaner intervention to improve home air quality will improve respiratory symptoms, quality of life, lung function and reduce risk of exacerbations in former smokers with COPD.

Hypothesis: An intervention using high-efficiency particulate air (HEPA) and carbon filter air cleaners in homes of former smokers with COPD will improve respiratory symptoms, quality of life, and lung function and reduce risk of COPD exacerbations compared with placebo (sham air cleaners).

Specific Aim #2: To determine whether an air cleaner intervention to improve home air quality will be associated with intermediate outcome measures known to be linked with long term outcomes in COPD, including airway and systemic markers of inflammation and oxidative stress, in former smokers with COPD.

Hypothesis 2: An intervention using HEPA and carbon filter air cleaners in homes of formers smokers with COPD will be associated with lower levels of markers of inflammation and oxidative stress known to be associated with adverse outcomes in patients with COPD.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

About this study

This research is being done to learn whether an air cleaner intervention to improve home air quality (particulate matter (PM) and nitrogen dioxide (NO2) reduction) will improve respiratory symptoms, quality of life, lung function, and reduce risk of exacerbations in former smokers with COPD.

The investigators will place air pollution monitors in the home to measure the air quality over five 1-week periods (at 3 month and 1 week pre-intervention, and 1 week, 3 months and 6 months post-intervention). During each week of monitoring, the investigators will ask that a diary be kept of breathing and how the participants are feeling every day.

Participant will have 5 home visits and 5 clinic visits and monthly telephone calls during this time to see how the participant is feeling. One week after each home visit, the monitoring equipment will be picked up. After the 2nd monitoring period, active or sham air cleaners will be placed in home.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 40 years,
  • Physician diagnosis of COPD,
  • Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) ≤70% and FEV1 (% predicted) <80%,
  • Tobacco exposure ≥ 10 pack-years, and
  • Former smoker. We will employ a combination of self-report and a biochemical marker to identify former-smokers. Exhaled CO (eCO) will be used as a marker of smoking status, as it is easy to perform, provides immediate data and is non-invasive. Former-smokers will be those who report no current smoking in the past 1 year AND have exhaled CO levels ≤ 6ppm. This threshold was chosen to maximize the chance of distinguishing true smokers and ex-smokers (>95%).

Exclusion criteria

  • Chronic systemic corticosteroids (≥ 3 months continuous use in past 12 months),
  • Other chronic lung disease including asthma,
  • Living in location other than home (e.g., long term care facility) and
  • Home owner or home occupant planning to move or change residence within the study period.

Treatment and study plan

HEPA air cleaner

Device

Air cleaners containing HEPA and carbon filters (Austin HealthMate HM400) and capable of removing PM and NO2 will be placed in the bedroom and room where the participant reports spending the most time.

Sham HEPA Air Cleaner

Device

Homes in the control group will receive sham air cleaners that have the internal HEPA and carbon filters removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status.

Primary outcomes

  1. Change in Quality of Life

    Time frame: Change from baseline and at 6 months post randomization

    St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more limitations

Secondary outcomes

  1. Health care utilization

    Time frame: Baseline through end of study (approximately 6 months post-randomization)

    Aggregate Exacerbations including (need for oral corticosteroids or antibiotics for worsening respiratory symptoms, emergency department (ED) visit or hospitalization).

    During this 6 months exacerbations will be collected at monthly telephone calls and at 3 and 6 month clinic visits. Whether an exacerbation occurred over this 6 month period will be assessed.

  2. Change in Dyspnea (mMRC)

    Time frame: Change from baseline and 3 months post-randomization

    Dyspnea will be assessed using the modified medical research Council questionnaire (mMRC). The total score is from 0 (no dyspnea) to 2 (severe dyspnea).

  3. Change in Dyspnea (mMRC)

    Time frame: Change from baseline and 6 months post-randomization

    Dyspnea will be assessed using the modified medical research Council questionnaire (mMRC). The total score is from 0 (no dyspnea) to 2 (severe dyspnea).

  4. Change in COPD health status

    Time frame: Change from baseline and 3 months post randomization

    Functional status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control

  5. Change in COPD health status

    Time frame: Change from baseline and 6 months post randomization

    Functional status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control

  6. Change in Functional status

    Time frame: Change from baseline and 3 months post randomization

    Functional status will be assessed with the 6 minute walk test. We will assess the distance (in meters) covered a time of 6 minutes.

  7. Change in Functional status

    Time frame: Change from baseline and 6 months post randomization

    Functional status will be assessed with the 6 minute walk test. We will assess the distance (in meters) covered a time of 6 minutes.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Sep 11, 2014
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.